[Feasibility of a screening instrument for adult attention-deficit/hyperactivity disorder (ASRS-5) in general practice: A qualitative study]. / Anwendbarkeit eines Screening-Instruments für die Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung bei Erwachsenen (ASRS-5) in der Hausarztpraxis ­ eine qualitative Studie.

OBJECTIVES: The aim of the study was to explore the subjective views of general practitioners on the applicability of the Adult ADHD Self-Report Screening Scale for DSM-5 (ASRS-5) as a screening tool for attention-deficit/hyperactivity disorder (ADHD) in adults in general practice. METHOD: Eleven general practitioners, who had participated in the validation study of the German version of the ASRS-5, were interviewed. For this purpose, a semi-structured interview guide was designed using the Consolidated Framework for Implementation Research (CFIR). The interviews were audio-recorded, transcribed, and analyzed using qualitative content analysis according to Kuckartz. RESULTS: The ASRS-5 seems to work well in general medical practice. But there is evidence for a lack of knowledge about ADHD in adults among general practitioners and a demand for further training in this area. Moreover, insufficient possibilities for subsequent treatment after a positive ADHD screening were claimed. DISCUSSION: In general medicine, the introduction of a screening using ASRS-5 in cases of clinical suspicion could be the first step towards improving the management of adult patients with ADHD. CONCLUSION: Optimizing the management of adults with ADHD requires additional information and training initiatives to support early diagnosis especially in the primary care setting, and to reveal treatment options and care concepts for adults with ADHD.

Anxiety and depression symptoms in adolescents and young adults with juvenile idiopathic arthritis: results of an outpatient screening.

BACKGROUND: Previous studies have shown that growing up with rheumatic conditions can fuel dissatisfaction and psychological distress, which in turn affects disease self-management and treatment adherence. Primary objective of this study was to estimate the prevalence of anxiety and depression symptoms in adolescents and young adults (AYA) with juvenile idiopathic arthritis (JIA) and to identify correlates of conspicuous screening results. METHODS: Initiated as part of the COACH multicenter observational study, outpatients aged 12 to 21 years participating in the National Pediatric Rheumatological Database (NPRD) were prospectively screened for mental health using the Patient Health Questionnaire-9 (PHQ-9) and the Generalised Anxiety Disorder Scale-7 (GAD-7). RESULTS: Data from 1,150 adolescents with JIA (mean age 15.6 ± 2.2 years; mean disease duration 7.2 ± 4.9 years, 69% female, 43% oligoarthritis, 26% polyarthritis) were analysed. Overall, 32.7% (n = 316) of AYA showed conspicuous screening results, of whom 30.4% reported clinically relevant suicidal or self-harm thoughts. About 19% of screened patients showed moderate to severe depressive or anxious symptoms. AYA with conspicuous screening results were older (15.8 vs. 15.2 years; p < 0.0001), more often female (81% vs. 64%; p < 0.0001) and more often overweight (25% vs. 17%; p = 0.006). They had higher disease activity (physician global assessment on NRS 0-10; 1.7 vs. 1.2; p < 0.0001), more functional limitations (CHAQ; 0.44 vs. 0.14; <0.0001) and rated their health status worse (NRS 0-10; 3.5 vs. 1.8; p < 0.0001) than AYA with inconspicuous screening results. Females (OR 2.33 [CI 1.53-3.56]; p < 0.0001), older age (OR 1.09 [CI 1.01-1.18]; p = 0.026), patients with more functional limitations (OR 3.36 [CI 1.98-5.72]; p < 0.0001), and patients with worse subjective health status (OR 1.17 [CI 1.07-1.27]; p < 0.0001) were more likely to have a conspicuous screening result. Regular sports participation was associated with a lower likelihood of conspicuous screening result (OR 0.69 [CI 0.49-0.98]; p = 0.039). CONCLUSIONS: A large-scale outpatient screening of AYA with JIA in Germany shows a high prevalence of anxiety and depression symptoms. The need for routine screening for early detection of mental health problems became apparent.

Perspectives of key informants before and after implementing UPSIDES peer support in mental health services: qualitative findings from an international multi-site study.

BACKGROUND: Peer support is an essential part of recovery-oriented care worldwide. Contextual factors have an impact on the implementation of peer support work. However, research has paid little attention to similarities and differences of implementation factors in settings varying by income-level and cultural values. The aim of this study is to assess the factors influencing the implementation of a peer support intervention across study sites in low-, middle- and high-income countries in line with the Consolidation Framework for Implementation Research (CFIR). METHOD: 6 focus groups with a total of 54 key informants with relevant contextual (organisational) knowledge regarding implementation facilitators and barriers were conducted at six study sites Ulm and Hamburg (Germany), Butabika (Uganda), Dar es Salaam (Tanzania), Be'er Sheva (Israel), and Pune (India) before and 1.5 years after the start of UPSIDES peer support. Transcripts were analysed using qualitative content analysis. RESULTS: Across study sites key informants reported benefits of peer support for service users and peer support workers as implementation facilitators. At study sites with lower resources, reduced workload for mental health workers and improved access to mental health services through peer support were perceived as implementation facilitators (CFIR Domain 1: Intervention characteristics). The degree of engagement of mental health workers (CFIR Domain 3: Inner Setting/Domain 4: Individuals involved) varied across study sites and was seen either as a barrier (low engagement) or a facilitator (high engagement). Across study sites, adequate training of peer support workers (CFIR Domain 5: Implementation process) was seen as animplementation facilitator, while COVID-19 as well as low resource availability were reported as implementation barriers (CFIR Domain 2: Outer setting). CONCLUSIONS: This study highlights the importance of considering contextual factors when implementing peer support, including previous experience and perceived benefits. Particular attention should be given to organisational benefits such as workload reduction and the allocation of sufficient resources as key drivers in LMICs. In HICs, the potential of organisational benefits for successful implementation should be further investigated and promoted.

Testing a model of benefit-finding and growth in youths with chronic health conditions.

BACKGROUND: The experience of benefit-finding and growth (BFG), defined as perceiving positive life changes resulting from adversity, is increasingly studied among youths with chronic health conditions (CCs). However, empirical evidence is scarce for explaining individual differences in BFG. The study aimed to test a model of BFG, including an interplay of personal and environmental factors and coping processes. METHODS: A sample of N = 498 youths (12-21 years) recruited from three German patient registries for CCs (type 1 diabetes: n = 388, juvenile idiopathic arthritis: n = 82, cystic fibrosis: n = 28) completed a questionnaire including self-reported optimism, social support from parents and peers, coping strategies, and BFG. The model was created to reflect the theoretical assumptions of the Life Crisis and Personal Growth model and current empirical evidence. Structural equation modeling was conducted to evaluate the incremental explanatory power of optimism, peer group integration, parental support, acceptance, cognitive reappraisal, and seeking social support over and above sociodemographic and disease-related characteristics. RESULTS: The model (CFI = 0.93; RMSEA = 0.04; SRMR = 0.05) explained 32% of the variance in BFG. Controlling for sociodemographic and disease-related characteristics, acceptance, cognitive reappraisal, and seeking social support were directly and positively linked to BFG. All tested coping strategies significantly mediated the association between optimism and BFG, whereas seeking social support significantly mediated the relation between peer group integration and BFG. DISCUSSION: The study stresses the prominent role of emotion-focused coping strategies and peer group integration in enhancing BFG in youths with CCs. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), no. DRKS00025125. Registered on May 17, 2021.

Societal and organisational influences on implementation of mental health peer support work in low-income and high-income settings: a qualitative focus group study.

OBJECTIVES: Despite the established evidence base for mental health peer support work, widespread implementation remains a challenge. This study aimed to explore societal and organisational influences on the implementation of peer support work in low-income and high-income settings. DESIGN: Study sites conducted two focus groups in local languages at each site, using a topic guide based on a conceptual framework describing eight peer support worker (PSW) principles and five implementation issues. Transcripts were translated into English and an inductive thematic analysis was conducted to characterise implementation influences. SETTING: The study took place in two tertiary and three secondary mental healthcare sites as part of the Using Peer Support in Developing Empowering Mental Health Services (UPSIDES) study, comprising three high-income sites (Hamburg and Ulm, Germany; Be'er Sheva, Israel) and two low-income sites (Dar es Salaam, Tanzania; Kampala, Uganda) chosen for diversity both in region and in experience of peer support work. PARTICIPANTS: 12 focus groups were conducted (including a total of 86 participants), across sites in Ulm (n=2), Hamburg (n=2), Dar es Salaam (n=2), Be'er Sheva (n=2) and Kampala (n=4). Three individual interviews were also done in Kampala. All participants met the inclusion criteria: aged over 18 years; actual or potential PSW or mental health clinician or hospital/community manager or regional/national policy-maker; and able to give informed consent. RESULTS: Six themes relating to implementation influences were identified: community and staff attitudes, resource availability, organisational culture, role definition, training and support and peer support network. CONCLUSIONS: This is the first multicountry study to explore societal attitudes and organisational culture influences on the implementation of peer support. Addressing community-level discrimination and developing a recovery orientation in mental health systems can contribute to effective implementation of peer support work. The relationship between societal stigma about mental health and resource allocation decisions warrants future investigation. TRIAL REGISTRATION NUMBER: ISRCTN26008944.

Good practice recommendations on implementation evaluation for policies targeting diet, physical activity, and sedentary behaviour.

Health policies aim to achieve specific health goals through system-level changes, unlike common health interventions that focus on promoting specific health behaviors on individual level. However, reliable data on the feasibility and implementation of policy actions across Europe are lacking. Moreover, no practice-oriented guidance exists for policy makers and implementers on how to evaluate policy implementation.As part of the Policy Evaluation Network, we aimed to synthesise knowledge on how to evaluate the implementation of policies promoting healthy diets, physical activity, and reducing sedentary behaviours. The multidisciplinary working group comprised 16 researchers and conducted two scoping reviews, three systematic reviews, two meta-reviews, two qualitative case studies and one quantitative case study over three years. The target populations included the general population, those at risk for obesity, and school children. Based on these reviews and case studies, this article summarises and presents the findings and lessons learned regarding the implementation evaluation of policies in nine case reports.Drawing on these experiences, three critical requirements for policy implementation evaluation were set: 1) conduct a comprehensive policy implementation evaluation from a multi-level perspective, 2) use implementation frameworks to address processes, determinants, and outcomes, and 3) engage relevant stakeholders in policy implementation evaluation. Finally, the consensus process resulted in 10 steps for the implementation evaluation of policies to promote physical activity and a healthy diet and to reduce sedentary behaviours, which adhere to the requirements and resources of the targeted policy.The findings of an implementation evaluation can lead to a better understanding of why policies work or not and can serve as a basis for developing solutions. This practice-oriented guidance outlines factors that should be considered in policy implementation evaluation to address its complexity. In this way, involved researchers and practitioners are empowered to engage in the evaluation process to close the knowledge gap regarding policy implementation.

Supporting SURgery with GEriatric Co-Management and AI (SURGE-Ahead): A study protocol for the development of a digital geriatrician.

INTRODUCTION: Geriatric co-management is known to improve treatment of older adults in various clinical settings, however, widespread application of the concept is limited due to restricted resources. Digitalization may offer options to overcome these shortages by providing structured, relevant information and decision support tools for medical professionals. We present the SURGE-Ahead project (Supporting SURgery with GEriatric co-management and Artificial Intelligence) addressing this challenge. METHODS: A digital application with a dashboard-style user interface will be developed, displaying 1) evidence-based recommendations for geriatric co-management and 2) artificial intelligence-enhanced suggestions for continuity of care (COC) decisions. The development and implementation of the SURGE-Ahead application (SAA) will follow the Medical research council framework for complex medical interventions. In the development phase a minimum geriatric data set (MGDS) will be defined that combines parametrized information from the hospital information system with a concise assessment battery and sensor data. Two literature reviews will be conducted to create an evidence base for co-management and COC suggestions that will be used to display guideline-compliant recommendations. Principles of machine learning will be used for further data processing and COC proposals for the postoperative course. In an observational and AI-development study, data will be collected in three surgical departments of a University Hospital (trauma surgery, general and visceral surgery, urology) for AI-training, feasibility testing of the MGDS and identification of co-management needs. Usability will be tested in a workshop with potential users. During a subsequent project phase, the SAA will be tested and evaluated in clinical routine, allowing its further improvement through an iterative process. DISCUSSION: The outline offers insights into a novel and comprehensive project that combines geriatric co-management with digital support tools to improve inpatient surgical care and continuity of care of older adults. TRIAL REGISTRATION: German clinical trials registry (Deutsches Register für klinische Studien, DRKS00030684), registered on 21st November 2022.

Diabetes in all hospitalized cases in Germany 2015-2019 and impact of the first COVID-19 year 2020.

Objective: To analyze the proportion of diabetes among all hospitalized cases in Germany between 2015 and 2020. Methods: Using the nationwide Diagnosis-Related-Groups statistics, we identified among all inpatient cases aged ≥ 20 years all types of diabetes in the main or secondary diagnoses based on ICD-10 codes, as well all COVID-19 diagnoses for 2020. Results: From 2015 to 2019, the proportion of cases with diabetes among all hospitalizations increased from 18.3% (3.01 of 16.45 million) to 18.5% (3.07 of 16.64 million). Although the total number of hospitalizations decreased in 2020, the proportion of cases with diabetes increased to 18.8% (2.73 of 14.50 million). The proportion of COVID-19 diagnosis was higher in cases with diabetes than in those without in all sex and age subgroups. The relative risk (RR) for a COVID-19 diagnosis in cases with vs without diabetes was highest in age group 40-49 years (RR in females: 1.51; in males: 1.41). Conclusions: The prevalence of diabetes in the hospital is twice as high as the prevalence in the general population and has increased further with the COVID-19 pandemic, underscoring the increased morbidity in this high-risk patient group. This study provides essential information that should help to better estimate the need for diabetological expertise in inpatient care settings.

Common procedures and conditions leading to inpatient hospital admissions in adults with and without diabetes from 2015 to 2019 in Germany : A comparison of frequency, length of hospital stay and complications.

OBJECTIVE: To evaluate common surgical procedures and admission causes in inpatient cases with diabetes in Germany between 2015 and 2019 and compare them to inpatient cases without diabetes. METHODS: Based on the German diagnosis-related groups (G-DRG) statistics, regression models stratified by age groups and gender were used to calculate hospital admissions/100,000 individuals, hospital days as well as the proportion of complications and mortality in inpatient cases ≥ 40 years with or without a documented diagnosis of diabetes (type 1 or type 2). RESULTS: A total of 14,222,326 (21%) of all inpatient cases aged ≥ 40 years had a diagnosis of diabetes. More middle-aged females with vs. without diabetes/100,000 individuals [95% CI] were observed, most pronounced in cases aged 40-< 50 years with myocardial infarction (305 [293-319] vs. 36 [36-37], p < 0.001). Higher proportions of complications and longer hospital stays were found for all procedures and morbidities in cases with diabetes. CONCLUSION: Earlier hospitalizations, longer hospital stays and more complications in inpatient cases with diabetes together with the predicted future increase in diabetes prevalence depict huge challenges for the German healthcare system. There is an urgent need for developing strategies to adequately care for patients with diabetes in hospital.

Prevalence of food insecurity in people with major depression, bipolar disorder, and schizophrenia and related psychoses: A systematic review and meta-analysis.

People with severe mental illness (SMI), such as major depression, bipolar disorder, and schizophrenia, experience numerous risk factors that may predispose them to food insecurity; however, the prevalence of food insecurity and its effects on health are under-researched in this population group. This systematic review and meta-analysis aimed to describe the prevalence and correlates of food insecurity in people with SMI. A comprehensive electronic search was conducted up to March 2021. Random effects meta-analysis was employed to determine the prevalence of food insecurity in SMI, and odds ratio (OR) of food insecurity in people with SMI compared to non-psychiatric controls/general population. Twenty-nine unique datasets (31 publications) were included. Prevalence estimate of food insecurity in people with SMI was 40% (95% CI 29-52%, I2 = 99.7%, N = 27). People with SMI were 2.71 (95% CI 1.72-3.25) times more likely to report food insecurity than the comparator group (Z = 11.09, p < 0.001, I2 = 95%, N = 23). The odds of food insecurity in SMI were higher in high/high-middle income countries compared to low/low-middle income countries, likely due to the high food insecurity rates in the general population of lower income countries. There was no difference in food insecurity rates by diagnosis. Food insecurity should be a consideration for health professionals working with community-dwelling people with SMI.

[Successful Implementation of Peer Support for People with Severe Mental Illness in Germany: a Theory of Change Approach]. / Eine Theory of Change zur erfolgreichen Implementierung von Peer-Begleitung für Menschen mit schweren psychischen Erkrankungen in Deutschland.

OBJECTIVE: Peer support is an established intervention in which people with mental illness receive support by trained peer support workers who have already overcome a mental health crisis. The implementation of peer support is complex due to interacting factors and can be achieved through the participatory Theory of Change method. Aim of this study is to develop a cross-site Theory of Change for the sustainable implementation of UPSIDES peer support in Germany. METHODS: Based on site-specific Theories of Change workshops from Ulm and Hamburg in which 47 participants took part, a cross-site Theory of Change was designed and verified in three follow-up workshops with 12 participants. Participants' professional and experiential backgrounds were diverse, including peer support workers, hospital directors and managers, mental health professionals (psychiatrists, psychotherapists, nurses), and researchers. RESULTS: The first pathway of the cross-site Theory of Change focuses on the training of peer support workers, whereas the second pathway emphasizes recognition and integration by mental health institutions and professionals. The third pathway specifies the building of a cross-professional care network to integrate various peer support services. Procedures to approach prospective peer clients are depicted in the fourth pathway. The fifth path addresses the clarification of the role description of peer support workers and the implementation in other institutions through cooperation. DISCUSSION: Many of the identified implementation steps have been validated in comparable studies. The development of this Theory of Change by bringing together multiple perspectives of key stakeholders is an important basis for the sustainable implementation of UPSIDES peer support. Furthermore, it may serve as a blueprint for the implementation of similar interventions to advance scaling-up of evidence-based user-led and recovery-oriented interventions. CONCLUSION: The Theory of Change approach is a well-accepted and feasible method, which can be recommended for the implementation of complex interventions such as UPSIDES peer support.

Implications of Dietary Intake and Eating Behaviors for People with Serious Mental Illness: A Qualitative Study.

The impact of poor diet quality and nutritional inadequacies on mental health and mental illness has recently gained considerable attention in science. As the opinions and experiences of people living with serious mental illness on dietary issues are unknown, we aimed to understand the role of nutrition in a biopsychosocial approach. In total, 28 semi-structured interviews were conducted with people living with serious mental illness (SMI) in Australia, Germany and Austria, and a generic thematic analysis approach was applied. Four positive (positive effects on the body and mind, therapeutic effects in treating somatic illnesses, pleasure and opportunity for self-efficacy) and three negative (impairment related to mental illness and its treatment, perceived stigma and negative effects on the body and mind) implications of diet were identified. A key issue for most of the participants was the mental burden arising from their body weight. This might indicate that negative implications, such as guilt and stigma, were of primary importance for people with SMI when talking about their dietary behavior. In conclusion, diet-related support is urgently needed for people with SMI. However, especially participants from Germany and Austria reported that this is not yet widely available in mental health settings, leading to hopelessness and resignation.

Effectiveness and cost-effectiveness of sector-independent treatment coordination for people with substance-related disorders following an online assessment (ASSIST): study protocol for a randomized controlled trial.

BACKGROUND: The implementation of person-centred, need-oriented and flexible care for people with substance-related problems is often insufficient, in large part due to the complexity of addiction support services among different providers. A standardized online assessment and subsequent sector-independent treatment coordination could provide individuals with more appropriate services, thereby making better use of individual services and leading to a more effective addiction support system as a whole. The aim of this study is to determine the effectiveness and cost-effectiveness of sector-independent treatment coordination following an online assessment, in comparison with the current standard of care and treatment process in Germany. METHODS: The sample size of this randomized, controlled trial has been set to a total of 400 participants with substance-related problems. Participants living in Stuttgart, Germany, will be randomly allocated to (1) the intervention group with immediate online assessment and subsequent sector-independent treatment coordination (ASSIST) or (2) the waitlist group. Participants in the waitlist group will initially remain in usual care and only be provided with the online assessment 6 months later. Short-term effects (over 2 months) and medium-term effects (over 6 months) of ASSIST will be compared between the intervention and the waitlist groups. The primary outcome is improved treatment satisfaction. Secondary outcomes include improved subjective quality of life and empowerment, reductions in patients' substance use, unmet needs and illness-related clinical and social impairment. Health economic evaluation as well as quantitative and qualitative process evaluations will be conducted. DISCUSSION: The results of this study are expected to provide information on whether sector-independent treatment coordination following an online assessment contributes to improved health care service provision for people with substance-related problems. This randomized controlled trial will help identify facilitators and barriers to the sustainable implementation of a cross-sectoral care concept in substance abuse services. TRIAL REGISTRATION: German Clinical Trial Register DRKS00026996 . Registered on 29 October 2021.

Exploration of Perceived Determinants of Disordered Eating Behaviors in People with Mental Illness-A Qualitative Study.

Disordered eating behaviors are common in people with a serious mental illness (SMI) such as schizophrenia, bipolar disorder and major depressive disorder. This study employed qualitative exploration to understand the perceived determinants of eating behaviors, in particular those connected to disordered eating patterns, in people with SMI. In total, 28 semi-structured interviews were conducted in a consecutive sample of people with SMI under treatment in local mental health services in Australia (n = 12), Germany (n = 8) and Austria (n = 8) (mean age: 43.3 years, proportion of female participants: 61%, proportion of participants with ICD-10 F2 diagnosis: 57%, proportion of participants with ICD-10 F3 diagnosis: 64%). A thematic analysis approach, the framework method, was applied using MAXQDA 2020. Three main themes of determinants were derived: (i) impacts to daily functioning, (ii) disrupted physical hunger cues and (iii) emotional hunger. For impacts to daily functioning, the following themes emerged: lack of daily structure, time and drive, and difficulty planning ahead. For physical hunger, themes emerged for disrupted hunger and satiety cues, and mindless eating. All motives listed in the Palatable Eating Motives Scale (PEMS), i.e., coping, reward, social and conformity, have been reported by participants to be drivers for their emotional eating behavior. Subsequent reported behaviors were eating too much or too little, binge eating, night eating and food cravings. We conclude that interprofessional approaches should target daily functioning, disrupted physical hunger cues and emotional eating to reduce disordered eating behaviors in people with SMI.

Quality of stroke guidelines in low- and middle-income countries: a systematic review.

OBJECTIVE: To identify gaps in national stroke guidelines that could be bridged to enhance the quality of stroke care services in low- and middle-income countries. METHODS: We systematically searched medical databases and websites of medical societies and contacted international organizations. Country-specific guidelines on care and control of stroke in any language published from 2010 to 2020 were eligible for inclusion. We reviewed each included guideline for coverage of four key components of stroke services (surveillance, prevention, acute care and rehabilitation). We also assessed compliance with the eight Institute of Medicine standards for clinical practice guidelines, the ease of implementation of guidelines and plans for dissemination to target audiences. FINDINGS: We reviewed 108 eligible guidelines from 47 countries, including four low-income, 24 middle-income and 19 high-income countries. Globally, fewer of the guidelines covered primary stroke prevention compared with other components of care, with none recommending surveillance. Guidelines on stroke in low- and middle-income countries fell short of the required standards for guideline development; breadth of target audience; coverage of the four components of stroke services; and adaptation to socioeconomic context. Fewer low- and middle-income country guidelines demonstrated transparency than those from high-income countries. Less than a quarter of guidelines encompassed detailed implementation plans and socioeconomic considerations. CONCLUSION: Guidelines on stroke in low- and middle-income countries need to be developed in conjunction with a wider category of health-care providers and stakeholders, with a full spectrum of translatable, context-appropriate interventions.

A prospective investigation of developmental trajectories of psychosocial adjustment in adolescents facing a chronic condition - study protocol of an observational, multi-center study.

BACKGROUND: Relatively little is known about protective factors and the emergence and maintenance of positive outcomes in the field of adolescents with chronic conditions. Therefore, the primary aim of the study is to acquire a deeper understanding of the dynamic process of resilience factors, coping strategies and psychosocial adjustment of adolescents living with chronic conditions. METHODS/DESIGN: We plan to consecutively recruit N = 450 adolescents (12-21 years) from three German patient registries for chronic conditions (type 1 diabetes, cystic fibrosis, or juvenile idiopathic arthritis). Based on screening for anxiety and depression, adolescents are assigned to two parallel groups - "inconspicuous" (PHQ-9 and GAD-7 < 7) vs. "conspicuous" (PHQ-9 or GAD-7 ≥ 7) - participating in a prospective online survey at baseline and 12-month follow-up. At two time points (T1, T2), we assess (1) intra- and interpersonal resiliency factors, (2) coping strategies, and (3) health-related quality of life, well-being, satisfaction with life, anxiety and depression. Using a cross-lagged panel design, we will examine the bidirectional longitudinal relations between resiliency factors and coping strategies, psychological adaptation, and psychosocial adjustment. To monitor Covid-19 pandemic effects, participants are also invited to take part in an intermediate online survey. DISCUSSION: The study will provide a deeper understanding of adaptive, potentially modifiable processes and will therefore help to develop novel, tailored interventions supporting a positive adaptation in youths with a chronic condition. These strategies should not only support those at risk but also promote the maintenance of a successful adaptation. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), no. DRKS00025125 . Registered on May 17, 2021.

Peer support for people with severe mental illness versus usual care in high-, middle- and low-income countries: study protocol for a pragmatic, multicentre, randomised controlled trial (UPSIDES-RCT).

BACKGROUND: Peer support is an established intervention involving a person recovering from mental illness supporting others with mental illness. Peer support is an under-used resource in global mental health. Building upon comprehensive formative research, this study will rigorously evaluate the impact of peer support at multiple levels, including service user outcomes (psychosocial and clinical), peer support worker outcomes (work role and empowerment), service outcomes (cost-effectiveness and return on investment), and implementation outcomes (adoption, sustainability and organisational change). METHODS: UPSIDES-RCT is a pragmatic, parallel-group, multicentre, randomised controlled trial assessing the effectiveness of using peer support in developing empowering mental health services (UPSIDES) at four measurement points over 1 year (baseline, 4-, 8- and 12-month follow-up), with embedded process evaluation and cost-effectiveness analysis. Research will take place in a range of high-, middle- and low-income countries (Germany, UK, Israel, India, Uganda and Tanzania). The primary outcome is social inclusion of service users with severe mental illness (N = 558; N = 93 per site) at 8-month follow-up, measured with the Social Inclusion Scale. Secondary outcomes include empowerment (using the Empowerment Scale), hope (using the HOPE scale), recovery (using Stages of Recovery) and health and social functioning (using the Health of the Nations Outcome Scales). Mixed-methods process evaluation will investigate mediators and moderators of effect and the implementation experiences of four UPSIDES stakeholder groups (service users, peer support workers, mental health workers and policy makers). A cost-effectiveness analysis examining cost-utility and health budget impact will estimate the value for money of UPSIDES peer support. DISCUSSION: The UPSIDES-RCT will explore the essential components necessary to create a peer support model in mental health care, while providing the evidence required to sustain and eventually scale-up the intervention in different cultural, organisational and resource settings. By actively involving and empowering service users, UPSIDES will move mental health systems toward a recovery orientation, emphasising user-centredness, community participation and the realisation of mental health as a human right. TRIAL REGISTRATION: ISRCTN, ISRCTN26008944. Registered on 30 October 2019.

Effectiveness and cost-effectiveness of guided Internet- and mobile-based CBT for adolescents and young adults with chronic somatic conditions and comorbid depression and anxiety symptoms (youthCOACHCD): study protocol for a multicentre randomized controlled trial.

BACKGROUND: Adolescents and young adults (AYA) with chronic somatic conditions have an increased risk of comorbid depression and anxiety symptoms. Internet- and mobile-based cognitive behavioural therapy (iCBT) might be one possibility to extend the access to evidence-based treatments. Studies suggest that guided iCBT can reduce anxiety and depression symptoms in AYA. However, little is known about the effectiveness of iCBT for AYA with chronic somatic conditions and comorbid symptoms of anxiety and/or depression in routine care. Evidence on the (cost-)effectiveness of iCBT is essential for its implementation in health care. OBJECTIVES AND METHODS: This multicentre two-armed randomized controlled trial (RCT) aims to evaluate the (cost-) effectiveness of guided iCBT (youthCOACHCD) in addition to treatment as usual (TAU) compared to enhanced treatment as usual (TAU+) in AYA aged 12-21 years with one of three chronic somatic conditions (type 1 diabetes, cystic fibrosis, or juvenile idiopathic arthritis). AYA with one of the chronic somatic conditions and elevated symptoms of anxiety or depression (Patient Health Questionnaire [PHQ-9] and/or Generalized Anxiety Disorder [GAD-7] Screener score ≥ 7) will be eligible for inclusion. We will recruit 212 patients (2 × n = 106) in routine care through three German patient registries. Assessments will take place at baseline and at 6 weeks, 3 months, 6 months, and 12 months post-randomization. The primary outcome will be combined depression and anxiety symptom severity as measured with the PHQ Anxiety and Depression Scale. Secondary outcomes will include health-related quality of life, coping strategies, self-efficacy, stress-related personal growth, social support, behavioural activation, adjustment and trauma-related symptoms, automatic thoughts, intervention satisfaction, working alliance, and Internet usage. The cost-effectiveness will be determined, and potential moderators and mediators of intervention effects will be explored. DISCUSSION: iCBT might implicate novel ways to increase the access to evidence-based interventions in this specific population. The distinct focus on effectiveness and cost-effectiveness of youthCOACHCD in patients with chronic somatic conditions, as well as intervention safety, will most likely provide important new insights in the field of paediatric e-mental health. A particular strength of the present study is its implementation directly into routine collaborative health care. As such, this study will provide important insights for health care policy and stakeholders and indicate how iCBT can be integrated into existing health care systems. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00017161. Registered on 17 September 2019.